ClinicalTrials.gg
CompletedNCT02325804Updated Apr 14, 2023

Effect of Specific Diet and Physical Activity on Weight and/or Fat Loss

An interventional study of Lifestyle Counseling in Obesity, sponsored by Slovak Academy of Sciences. Completed at 1 site in Slovakia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Obesity with a site in Slovakia — 9 open to participants now, 17 under way, 14 of them phase 3. Obesity · Slovakia.

Enrollment
29th of 34
60 · median 632
Started
2014
the only one that year
No phase
6 of 34
1 open now
Registered
5th of 34
by date
Lead sponsor
5 of 34
Slovak Academy of Sciences

Among the 34 studies in Obesity with a site in Slovakia, this one is the 29th largest by enrollment, is the only one that started in 2014, is one of 6 with no phase, and was the 5th registered.

By phase

34 studies; the count open now beside each. This study's row is marked.

Phase 324 · 7 open
No phasethis study6 · 1 open
Phase 12 · 1 open
Phase 22 · 0 open

By the year they started

First in 2006; this study’s year is marked. 1 started in 2014.

Size and results

Median enrollment 632 across the 34 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 34 studies in Obesity with a site in Slovakia, or all of them as a file.
02

Study summary

The main purpose of this study is to assess metabolic effects (decreased amount of body fat content, insulin sensitivity and lipid profile improvement) of weight loss intervention based on specific life style counseling (low calorie "metabolic stairs" diet and circuit-based exercise in a comparison to conventional diet and exercise. The main hypothesis is that more significant beneficial metabolic effects will have specific life style counseling effect than conventional diet and exercise. The main purpose of this study is to assess above mentioned metabolic changes before and after 6-8 weeks of weight loss intervention.

The investigators will also study the following:

  1. The impact of life style counseling induced weight and/or fat loss on physical fitness
  2. The impact of life style counseling induced weight and/or fat loss on metabolic parameters (e.g. insulin sensitivity, lipid profile, ect.)
Read the detailed description

I

03

Conditions studied

  • Obesity

Keywords

  • overweight and obesity
  • adipose tissue
  • weight loss program
  • low-calorie diet
  • circuit-based exercise
  • metabolic cardiovascular syndrome
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy Volunteers
  • ≥25 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Thyroid disease
  • Chronic diseases(rheumatic,liver, kidney, pulmonary, etc. diseases) have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or diabetes;
  • chronic infections
  • show evidence of
  • be women who are pregnant, nursing
  • medical treatment except allergy medicines
  • tobacco, alcohol or drug addiction
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Conventional lifestyle counseling

    Randomized, open label study to assess effect of 8 weeks of Conventional lifestyle counseling (low calorie diet and exercise) on body composition, physical fitness, and metabolic parameters

    Behavioral: Lifestyle Counseling

  • Active comparator
    Unconventional lifestyle counseling

    Randomized, open label study to assess effect of 8 weeks of unconventional lifestyle counseling (low calorie "metabolic stairs" diet and circuit-based exercise) on body composition, physical fitness, and metabolic parameters

    Behavioral: Lifestyle Counseling

Interventions

  • BehavioralLifestyle Counseling

    In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.

06

What researchers measure

Primary outcomes

  1. A Body weight change after specific weight loss intervention

    To assess the body composition changes (fat-free mass and fat mass (in kg)).

    Time frame: 8 weeks

Secondary outcomes

  1. Metabolic parameters

    * Insulin sensitivity * Total, HDL, LDL, small dense-LDL cholesterol levels

    Time frame: 8 weeks

07

Study locations

1 site
  • Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch
    Bratislava, 84505, Slovakia
08

References and documents

Publications

  • Balaz M, Vician M, Janakova Z, Kurdiova T, Surova M, Imrich R, Majercikova Z, Penesova A, Vlcek M, Kiss A, Belan V, Klimes I, Olejnik J, Gasperikova D, Wolfrum C, Ukropcova B, Ukropec J. Subcutaneous adipose tissue zinc-alpha2-glycoprotein is associated with adipose tissue and whole-body insulin sensitivity. Obesity (Silver Spring). 2014 Aug;22(8):1821-9. doi: 10.1002/oby.20764. Epub 2014 Apr 22. PubMed 24753506 ↗
  • Penesova A, Radikova Z, Vlcek M, Kerlik J, Lukac J, Rovensky J, Imrich R. Chronic inflammation and low-dose glucocorticoid effects on glucose metabolism in premenopausal females with rheumatoid arthritis free of conventional metabolic risk factors. Physiol Res. 2013;62(1):75-83. doi: 10.33549/physiolres.932359. Epub 2012 Nov 22. PubMed 23173679 ↗
  • Penesova A, Venti CA, Bunt JC, Bonfiglio SM, Votruba SB, Krakoff J. Short-term isocaloric manipulation of carbohydrate intake: effect on subsequent ad libitum energy intake. Eur J Nutr. 2011 Sep;50(6):455-63. doi: 10.1007/s00394-010-0152-5. Epub 2010 Dec 17. PubMed 21165629 ↗
  • Penesova A, Cizmarova E, Belan V, Blazicek P, Imrich R, Vlcek M, Vigas M, Selko D, Koska J, Radikova Z. Insulin resistance in young, lean male subjects with essential hypertension. J Hum Hypertens. 2011 Jun;25(6):391-400. doi: 10.1038/jhh.2010.72. Epub 2010 Jul 15. Erratum In: J Hum Hypertens. 2014 Mar;28(3):212. PubMed 20631738 ↗
  • Penesova A, Bunt JC, Bogardus C, Krakoff J. Effect of paternal diabetes on pre-diabetic phenotypes in adult offspring. Diabetes Care. 2010 Aug;33(8):1823-8. doi: 10.2337/dc10-0664. Epub 2010 Jun 2. PubMed 20519666 ↗
  • Eckertova M, Krskova K, Penesova A, Radikova Z, Zlnay D, Rovensky J, Zorad S. Impaired insulin secretion and uptake in patients with diffuse idiopathic skeletal hyperostosis. Endocr Regul. 2009 Oct;43(4):149-55. PubMed 19908933 ↗
  • Penesova A, Radikova Z, Cizmarova E, Kvetnansky R, Blazicek P, Vlcek M, Koska J, Vigas M. The role of norepinephrine and insulin resistance in an early stage of hypertension. Ann N Y Acad Sci. 2008 Dec;1148:490-4. doi: 10.1196/annals.1410.036. PubMed 19120146 ↗
  • Ukropec J, Penesova A, Skopkova M, Pura M, Vlcek M, Radikova Z, Imrich R, Ukropcova B, Tajtakova M, Koska J, Zorad S, Belan V, Vanuga P, Payer J, Eckel J, Klimes I, Gasperikova D. Adipokine protein expression pattern in growth hormone deficiency predisposes to the increased fat cell size and the whole body metabolic derangements. J Clin Endocrinol Metab. 2008 Jun;93(6):2255-62. doi: 10.1210/jc.2007-2188. Epub 2008 Mar 11. PubMed 18334583 ↗
  • Skopkova M, Penesova A, Sell H, Radikova Z, Vlcek M, Imrich R, Koska J, Ukropec J, Eckel J, Klimes I, Gasperikova D. Protein array reveals differentially expressed proteins in subcutaneous adipose tissue in obesity. Obesity (Silver Spring). 2007 Oct;15(10):2396-406. doi: 10.1038/oby.2007.285. PubMed 17925465 ↗
  • Jurkovicova D, Sedlakova B, Riecansky I, Goncalvesova E, Penesova A, Kvetnansky R, Krizanova O. Cardiovascular diseases and molecular variants of the renin-angiotensin system components in Slovak population. Gen Physiol Biophys. 2007 Mar;26(1):27-32. PubMed 17579251 ↗
  • Penesova A, Cizmarova E, Kvetnansky R, Koska J, Sedlakova B, Krizanova O. Insertion/deletion polymorphism on ACE gene is associated with endothelial dysfunction in young patients with hypertension. Horm Metab Res. 2006 Sep;38(9):592-7. doi: 10.1055/s-2006-951307. PubMed 16981142 ↗
  • Penesova A, Rovensky J, Zlnay M, Dedik L, Radikova Z, Koska J, Vigas M, Imrich R. Attenuated insulin response and normal insulin sensitivity in lean patients with ankylosing spondylitis. Int J Clin Pharmacol Res. 2005;25(3):107-14. PubMed 16366418 ↗
  • Penesova A, Radikova Z. Comparison of insulin sensitivity indices calculated from standard 3-sampled and frequently sampled oral glucose tolerance test. Endocr Regul. 2004 Dec;38(4):167-71. PubMed 15841797 ↗
  • Bajer B, Radikova Z, Havranova A, Zitnanova I, Vlcek M, Imrich R, Sabaka P, Bendzala M, Penesova A. Effect of 8-weeks intensive lifestyle intervention on LDL and HDL subfractions. Obes Res Clin Pract. 2019 Nov-Dec;13(6):586-593. doi: 10.1016/j.orcp.2019.10.010. Epub 2019 Dec 2. PubMed 31806470 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Mar 2023 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2014
First posted
Dec 25, 2014
Start
Dec 2014
Primary completionActual
Mar 2023
CompletionActual
Mar 2023
Last update
Apr 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02325804
Lead sponsor
Slovak Academy of Sciences
Responsible party
Adela Penesova, MD, PhD (Biomedical Center of Slovak Academy of Sciences, Institute of clinical and translational research, Slovak Academy of Sciences) — Principal investigator
First posted
Dec 25, 2014
Start date
Dec 2014
Primary completion
Mar 2023
Completion
Mar 2023
Last update
Apr 14, 2023

Study contacts

Adela Penesova, MD, PhD
principal investigator · Biomedical center, Slovak Academy of Sciences, Institute of clinical and translational researchBratislava, 833 06, SLOVAKIA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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